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CIPROXR

Phase 1

Fasting | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jun 13, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01372345Bioavailability Study of Ciprofloxacin 1000 mg ER Tablets of Dr. Reddy's Under Fasting ConditionsPHASE1 COMPLETED 43Feb 1, 2005Mar 1, 2005Jun 13, 20111 United States
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Study Endpoints
Primary Endpoints
Bioequivalence on Cmax and AUC parameters
3 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CiprofloxacinEXPERIMENTALCiprofloxacin Extended Release Tablets of Dr. Reddy's Laboratories Limited
CIPRO®XRACTIVE_COMPARATORCIPRO® XR (Bayer Health Care, Bayer Pharmaceuticals Corporation) Tablets
Interventions
NameTypeDescription
CIPRO®XRDRUGCiprofloxacin 1000 mg Tablets Dr. Reddy's Laboratories Limited
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Non-institutionalized subjects consisting of members of, the coInmunity at large. 2. All subjects selected for this study will be non-smokers between 18 and 45 years of age (inclusive). Female subjects must be unable to become pregnant (postmenopausal for at least 1 year, or ...

Countries:United States
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